Long-Term Therapy with Cuban Policosanol on Hypercholesterolemic Elder Patients: Analysis by Gender

Cardiovascular Disease is the leading cause of morbidity and mortality in the adult population. End-point based studies have been demonstrated a direct relationship between coronary artery disease and elevated serum levels of low density lipoprotein cholesterol (LDL-C) and total cholesterol, as well as the benefits of lowering LDL-C and increasing high density lipoprotein cholesterol (HDLC) on clinical end-points. Cuban policosanol is a mixture of saturated long-chain fatty alcohols, purified from sugarcane wax, which exhibits effects on the control of dyslipidemia, with demonstrated effectiveness, safety and tolerability in numerous clinical trials. Objectives: To investigate whether the results of policosanol treatment show any difference by sex in the elderly. Methods: In a previous long-term study old patients of both sexes with type II hypercholesterolemia, between 60 to 80 years old with  1 non-lipid coronary risk factors were randomized in two groups. The patients were treated with policosanol or placebo, during 3 years. The incidence of vascular side adverse events (SAE) occurred during the study was considered as a primary efficacy variable. Changes on lipid profile were considered secondary efficacy variables. In the present report it is analyzed differences of policosanol effects between genders. The analysis of variables was by Intention-totreat method. Results: The frequency of all SAE was lower in the policosanol group compared with placebo in both sexes. There were 63 SAE in placebo (10.8 %) and 17 in policosanol treated women (3.0 %) (p<0.00001). In turn, there were 20 SAE in placebo (13.2 %) and 9 in policosanol treated men (5.4 %) (p<0.01). Policosanol reduced all vascular SAE in both sexes. Thus, there were 34 vascular SAE in placebo (5.8 %) and 9 in policosanol treated women (1.6 %) (p<0.0001), while 15 vascular SAE occurred in placebo (9.9 %) and 6 in policosanol treated men (3.6 %) (p<0.01). Policosanol reduced cardiovascular SAE in both sexes. Thus, 21 cardiovascular SAE (3.6 %) occurred in placebo and 4 in policosanol treated women (0.7 %) (p<0.001), whereas 12 events (7.9 %) occurred in placebo and 3 (1.8 %) in policosanol treated men (p<0.01). Benefits were evident in both sexes, but greater in women. At study completion, the changes induced by policosanol in LDL-C, total cholesterol, triglycerides and HDL-C with respect to baseline were similar by gender. Conclusions: The present results demonstrate that treatment with policosanol significa